Protocol GELLC-7: Ibrutinib Followed by Ibrutinib Consolidation in Combination With Ofatumumab
Status:
Active, not recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
Based on the promising results obtained with ibrutinib as single agent, the results obtained
with ibrutinib in combination with ofatumumab in a previous phase I/IIb study (Jaglowski
2015), and since data from in vitro studies do not support a synergistic effect of the
combination of ibrutinib and anti-CD20 mAbs, we propose a chemotherapy-free combined strategy
based on ibrutinib monotherapy as front line treatment for patients with CLL, with the
addition of a consolidation phase with ofatumumab in patients not attaining CR under
ibrutinib in order to improve the quality of their response. Since median time to CR with
ibrutinib was nearly 12 months, patients will be evaluated at this time point, and those
patients not in CR will add consolidated treatment with Ofatumumab. Thus, this multi-center,
non-randomized phase 2 study is designed to evaluate the efficacy and safety of ibrutinib
alone or in combination with Ofatumumab in patients no attaining CR under ibrutinib as
front-line therapy for patients with chronic lymphocytic leukemia.